Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

March 6, 2018 updated by: Instituto de Investigacion Sanitaria La Fe

Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer

The aim of the study is to prove that acupuncture applied before and after embryo transfer is able to increase pregnancy rates by means of reducing stress and improving endometrial vascularization in women receiving in vitro Fertilization (IVF) treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at home. Most of the women undergoing those techniques suffer in some extent anxiety, depression and stress. Stress make IVF results worse and it has been prove by correlating cortisol, adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the sympathetic system and this capacity improves vascularization in uterus and ovaries. Available literature concerning these two issues is not conclusive because of studies design. Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has not been completely described; if it really has one. Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given that no randomized three arms study comparing no intervention to sham acupuncture to acupuncture has been published.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Human Reproduction Unit of the University and Politechnic Hospital La Fe.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 to 37 years old
  • 18-28 Body mass index (BMI)
  • Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility
  • No previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatments
  • No previous experience of acupuncture treatments
  • At least one high quality embryo in the day of uterine transfer

Exclusion Criteria:

  • Polycystic ovarian syndrome
  • Endometriosis
  • Reproductive surgeries: any on uterus, fallopian tubes or ovaries
  • Ovarian cysts >20mm at the beginning of the stimulation cycle
  • Hormone treatment in the previous three months of the stimulation cycle, including oral contraceptives
  • Previous miscarriages and ectopic pregnancies
  • Coasting
  • Oestradiol levels >3500pg/ml or ovarian size >65mm in human chorio gonadotropin (hCG) day.
  • Failure to keep confidentiality
  • Concomitant illness or severe adverse reaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: SHAM ACUPUNCTURE
Sham intervention: acupuncture needle without puncture nor stimulation
Procedure: Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Procedure: Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Experimental: REAL ACUPUNCTURE
Experimental: acupuncture in selected points of the protocol designed
Procedure: Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Procedure: Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Other: Control
Bed Rest
Other: Bed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 14 days after embryo transfer
Heart beating in intrauterus embryo
14 days after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating preconceived ideas about acupuncture
Time Frame: From 24 hours (h) to 14 days after embryo transfer
Rating preconceived ideas about acupuncture
From 24 hours (h) to 14 days after embryo transfer
Determination of serum prolactin and 24h urine cortisol.
Time Frame: The day of embryo transfer (+14 days post-cycle start)).
Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer.
The day of embryo transfer (+14 days post-cycle start)).
Endometrial vascularization study
Time Frame: The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.
Endometrial vascularization study on the day of embryo transfer, 2 days before and after it
The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.
Analysis of the results of assisted reproductive cycle
Time Frame: After 14 days post-transfer (28 days after cycle star)
Analysis of the results of assisted reproductive cycle on levels of beta human chorionic gonadotropin (BhCG) +14 days post-transfer, evidence of intrauterine gestational sac with heartbeat and embryo live birth at home
After 14 days post-transfer (28 days after cycle star)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Monica Romeu, Doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACU2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe